FDA accepts Teva's Quartette NDA; OKs Sanofi's Auvi-Q

There was good news for Teva Pharmaceutical Industries this week after its women's health subsidiary announced that US regulators have accepted a filing for its experimental birth control pill Quartette.

The US Food and Drug Administration has agreed to review the firm's New Drug Application, which seeks to market Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) as the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy.

According to Teva, the submission is based on a clinical development program involving more than 3,000 females, which helped to determine the drug's safety and efficacy profile as a contraceptive with reduced breakthrough bleeding.

"We looked at when and why breakthrough bleeding occurs and designed Quartette to have less disruptive, unscheduled bleeding,” said Nancy Ricciotti, senior director of clinical affairs of Teva Women's Health R&D.

Meanwhile, the FDA has given clearance to Sanofi to market its Auvi-Q (epinephrine injection) for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.

According to Sanofi, Auvi-Q is the first-and-only compact epinephrine auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.

The firm points to surveys showing that two-thirds of patients and caregivers do not carry their potentially life-saving epinephrine auto-injectors as recommended, as almost half worry that others will not know how to use the device in an emergency.

It is hoped that the availability Auvi-Q could help to address this, as it talks users through each stage of the injection process.

"We are confident that Auvi-Q will provide the up to six million Americans at risk for anaphylaxis and their caregivers an easy-to-use compact option with unique features to help manage a life-threatening allergic reaction,” said Bryan Downey, vice president, Auvi-Q, Sanofi US.